ENHANCED ANTICARIES EFFICACY OF A 0.243-PERCENT SODIUM-FLUORIDE 10-PERCENT XYLITOL SILICA DENTIFRICE - 3-YEAR CLINICAL-RESULTS

Purpose: To evaluate the efficacy of a sodium fluoride (NaF)/silica/xy litol dentifrice compared with that of a positive control NaF/silica d entifrice on caries increments in school children over a 3-year period in an area without an optimal level of fluoride in the drinking water (mean level < 0.1 ppm). Materials and Methods: A 3-year, double-blind clinical caries study was conducted in 2,630 children initially aged 8-10 years at 17 schools in the San Jose, Costa Rica metropolitan area . Clinical dental examinations were performed at participating schools utilizing portable dental equipment. Caries evaluations employed conv entional tactile/visual methodology consisting of artificial light, de ntal mirrors and single-edge #23 explorers. Children accepted into the study were stratified by age and sex into two balanced groups within each school, and randomly assigned to use either a positive control de ntifrice containing 0.243% NaF/silica or a test dentifrice containing 0.243% NaF/silica/10% xylitol. Children were instructed to brush with the assigned dentifrice twice daily. Caries evaluations were conducted at baseline, 2 years, and 3 years. Results: After 3 years, subjects u sing the 0.243% NaF/silica/10% xylitol dentifrice had statistically si gnificantly reduced decayed/filled surfaces (DFS; - 12.3% reduction; P less than or equal to 0.001) and decayed/filled buccal and lingual su rfaces (DFS-BL; -10.5% reduction; P less than or equal to 0.01).